Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of aortic root reinforcement combined with vascular grafts eversion and built-in procedure (xj-procedure) in patients with acute type a aortic dissection (advanced-xj )

Conditions: Type A Aortic Dissection

Summary: this is a retrospective study based on the data available in our hospital database for ataad patients from january 2020 to december 2021. these patients were divided into two groups according to the surgical procedures of aortic root. this study compared baseline data, perioperative and short-term follow-up results between the two groups to evaluate the efficacy and safety of xj-procedure in ataad.

acute type a aortic dissection (ataad) is a life-threatening disease with high mortality. surgery remains the gold standard for the treatment of ataad. in recent years, ataad is still a persistent challenge for cardiovascular surgeons. this is a retrospective study based on the data available in our hospital database for ataad patients undergoing total aortic arch replacement with elephant trunk stent under cryogenic stop circulation from january 2020 to december 2021. these patients were divided into two groups according to the surgical procedures of aortic root: continuous aortic root suture group (cars group); "aortic root reinforcement combined with vascular grafts eversion and built-in", which was created by our group and to be named as xj-procedure (xj-procedure group, xj is an acronym for xi'an jiaotong university). the main outcome was defined as 30-day mortality. secondary outcomes included the postoperative bleeding necessitating re-operation and the incidence of anastomotic pseudoaneurysm, residual aortic root dissection and severe aortic regurgitation before discharge and at 3 and 6 months after the operation. this study compared baseline data, perioperative and short-term follow-up results between the two groups to evaluate the efficacy and safety of xj-procedure in ataad.

Eligibility criteria:
inclusion criteria: * diagnosed with ataad by computed tomography angiography (cta) from january 2020 to december 2021 in the first affiliated hospital of xi'an jiaotong university * mild to moderate aortic root involvement * aortic arch involvement undergoing sun's procedure exclusion criteria: * patients with severe aortic root involvement (root diameter \>45 mm, root tear, severe disruption of aortic root, concomitant valve disease) * the bentall, wheat or david procedure performed * recurrent ataad * preoperative severe brain complications (cerebral infarction, cerebral hemorrhage, coma, etc.) * mal-perfusion of abdominal organs or lower extremities \>12 h * incomplete clinical data.

Keywords: type a aortic dissection
added value of pet/ct in lung cancer

Conditions: Lung Cancer

Summary: assess the value of pet/ct in the diagnosis, staging, response evaluation, and relapse monitoring of lung cancer.

lung cancer is a leading cause of cancer-related mortality worldwide, accounted for 1.80 million deaths in 2020.(1)egyptian statistics showed that lung cancer in men represents 8.2% of among all cancers of men according to the egyptian national cancer program in 2014 (3).epidemiological data indicate that the main risk factor for the development of lung cancer is cigarette smoking.(4)lung cancer is histologically divided into: non-small-cell lung cancer (nsclc), which accounts for 85% of cases and small cell lung cancer (sclc).(5)due to absence of screening, most patients with lung cancer are not diagnosed until later stages, when the prognosis is poor.(6)radiologic manifestations of bronchogenic carcinoma include obstructive pneumonitis or atelectasis, lung nodule or mass, apical mass, cavitated mass, or nodule or mass associated with lymphadenopathy(6)conventional chest radiography, computed tomography (ct), magnetic resonance imaging, radionuclide scintigraphy, and positron emission tomography (pet) all have been used for nsclc staging.(7)pet/ct is a well-established radiological modality with high diagnostic accuracy in metastases detection compared to usual ct. also, it has been reported that up to 10% of patients with bronchogenic carcinoma are found to have metastases on pet/ct that were not detected on ct with subsequent different patients' staging. the high accuracy of pet/ct in tumor staging makes it important for the treatment strategy of either surgical treatment, radiotherapy, or chemotherapy. also, it becomes essential during the follow-up to detect recurrence. pet/ct shows a higher ability to evaluate the early response to the treatment as chemotherapy by its ability to detect the metabolic response even before the size change.(8)the prognosis of lung tumors depends on early and accurate staging as well as the histopathological type of the primary tumor, with the squamous cell carcinoma type regarded to be of a worse prognosis than that of adenocarcinoma.(9)

Eligibility criteria:
inclusion criteria: * pathologically proven lung cancer patients. exclusion criteria: * patients with second malignancy. * severely ill patient (patient with disturbed consciousness level, or couldn't lie during the imaging). * uncontrolled diabetic patient with blood glucose level more than 200mg\\dl. * pregnant women. * patient age \<18 years.

Keywords: pet-ct lung cancer
p53-adjusted neoadjuvant chemotherapy for potentially resectable esophageal cancer

Conditions: Esophageal Cancer

Summary: study hypothesis: pancho is a prospective randomized, predictive marker study, evaluating the interaction between the potential predictive marker 'p53 genotype' and response to induction chemotherapy in patients with esophageal cancer considered resectable. 170 patients with measurable disease will be enrolled in this study. after testing the marker genotype (two genotypes: p53 normal or p53 mutant) patients will be stratified according to histological subtype only (adeno- or squamous cell carcinoma) and will be randomly assigned to receive 3 cycles of either 5-fluorouracil (5fu)/cisplatin or docetaxel monotherapy as neoadjuvant therapy. all patients will be rendered to subsequent surgery in order to assess both clinical and pathohistological response.

pancho will test the hypothesis that p53 genotype is predictive for response to chemotherapy. the study uses the marker by treatment interaction design. in this design, we assume that the status of the marker splits the whole population into two distinct groups (p53 normal versus p53 mutant). patients in each marker group are randomly assigned to two different treatments, and planned statistical analysis is to test whether one treatment is superior to the other within each marker group separately. the marker information but not the treatment is blinded to the patient and the investigators.

Eligibility criteria:
inclusion criteria: * histological verification of esophageal cancer * presence of t2,t3,t4 or any n1 (except m1) * clinically measurable lesions according to recist criteria * males and females, age \>18 to 75 or older with who performance status 1 * no prior tumor therapy for esophageal cancer * no other malignancy in history within 5 years before evaluation * performance status of 0-2 on ecog scale * medical fitness (adequate for possible esophageal resection, adequate organ function: see protocol) * signed informed consent * males and females with reproductive potential must use an approved contraceptive method. females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment. exclusion criteria: * inoperability (technical or functional) * clinical stage ct1n0, any m1 * treatment with any of the investigational drugs within the last 6 months * concurrent administration of any other tumor therapy * pregnancy, breast feeding * serious concomitant disorders that would compromise the safety of the patient or ability to complete the study * second primary malignancy that is clinically detectable at the time of consideration for study enrollment

Keywords: predictive marker personalized therapy response assessment p53 genotype
bioelectric field imaging in diagnosing melanoma and other skin cancers in patients with skin lesions

Conditions: Melanoma (Skin); Non-melanomatous Skin Cancer

Summary: rationale: new diagnostic procedures, such as bioelectric field imaging, may help find and diagnose melanoma and other skin cancers. it may also be a less invasive way to check for skin cancer. purpose: this phase i trial is studying bioelectric field imaging in diagnosing melanoma and other skin cancers in patients with skin lesions.

objectives: * to determine if the hand-held bioelectric field imager can be used to measure the electric field in skin of various body surfaces, including face, neck, shoulders, arms, hands, chest, back, legs, and feet, during the course of examination and treatment of patients with suspected malignant skin lesions. * to determine if there is a significant difference between the lateral electric field strength near benign and malignant skin lesions in the same individual. outline: patients undergo scanning of their skin lesions and nearby healthy skin using the bioelectric field imager (bfi). the lesions are then biopsied for histological diagnosis. histological data from the biopsy is correlated with the electric field data from the bfi.

Eligibility criteria:
disease characteristics: * suspected malignant skin lesion * seeking treatment for skin lesion at the va medical center patient characteristics: * not pregnant * no acute illness, including upper respiratory tract infection or flu that could result in fever * no trauma to the skin lesion area * no prisoners prior concurrent therapy: * see disease characteristics

Keywords: melanoma basal cell carcinoma of the skin squamous cell carcinoma of the skin
a clinical study to learn if sep-363856 has physical dependence in adults with schizophrenia

Conditions: Schizophrenia

Summary: a clinical study to learn if sep-363856 has physical dependence in adults with schizophrenia. this study will be held in approximately 6 study sites in the united states. it will be accepting male and female participants age 18 years to 65 years. participation will be up to approximately10 weeks.

this is a double-blind, placebo-controlled, randomized withdrawal study comparing abrupt discontinuation of sep-363856 (sep-363856 switched to placebo) to continuous sep-363856 treatment in male and female adult subjects with schizophrenia.

Eligibility criteria:
inclusion criteria: (this list is not all inclusive) * male or female subject between 18 and 65 years of age (inclusive) at the time of informed consent. * subject meets diagnostic and statistical manual of mental disorders (dsm-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview (using the dsm-5 as a reference and confirmed using the structured clinical interview for dsm-5, clinical trials version \[scid-ct\]). * subject must have a clinical global impression-severity scale (cgi-s) score ≤ 4 (normal to moderately ill) at screening and day 1. * subject must have a panss total score ≤ 80 at screening and a score of ≤ 4 on the following panss items at screening: p7 (hostility) and g8 (uncooperativeness). * subject has been taking an antipsychotic for at least 6 weeks prior to screening and has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes may be permitted) for at least 6 weeks prior to screening. exclusion criteria: (this list is not all inclusive) * subject has a dsm-5 diagnosis or presence of symptoms consistent with a current dsm-5 diagnosis other than schizophrenia. * subject has attempted suicide within 6 months prior to screening. * subject answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the columbia suicide severity rating scale (c-ssrs) at screening (ie, in the past 1 month) or at any subsequent c-ssrs assessment prior to dosing (ie, since last visit). * subject is at significant risk of harming him/herself or others (passive or active) according to the investigator's judgment.

Keywords: schizophrenia
treatment with nelfinavir or efavirenz of hiv-infected patients who have never received anti-hiv drugs

Conditions: HIV Infections

Summary: the purpose of this study is to compare two drugs (nelfinavir \[nfv\] and efavirenz \[efv\]) used in start-up anti-hiv treatment. doctors want to see if one is better than the other in extending the time that viral load (level of hiv in the blood) is kept low. the study will also look at the response of the immune system to each drug.

patients are randomized to initiate therapy and receive either nelfinavir (nfv) or efavirenz (efv) in the first regimen (r1). all patients also receive zidovudine (azt) and lamivudine (3tc). patients are further randomized in a factorial fashion and by stratification based on hiv rna level (less than 10,000, 10,000-100,000, or greater than 100,000 copies/ml) to be administered a single injection of a neo-antigen (klh) at week 12, 24, or 48. therapy continues until switch criteria are met either before or after week 24. when switch criteria are met, patients advance to the next regimen (r2). r2 patients previously taking nfv switch to efv; those randomized to efv switch to nfv; the additional nrtis change to stavudine (d4t) and didanosine (ddi). therapy is continued for an additional 24 weeks.

Eligibility criteria:
inclusion criteria patients may be eligible for this trial if they: * are hiv-positive. * have a cd4 count of at least 100 cells/mm3. * have a viral load of at least 5,000 copies/ml. exclusion criteria patients may not be eligible for this study if they: * have taken any antiretroviral (anti-hiv) agent.

Keywords: hiv-1 drug therapy, combination lymphoid tissue hiv protease inhibitors genotype phenotype nelfinavir reverse transcriptase inhibitors anti-hiv agents viral load adipose tissue glucose lipids immunophenotyping efavirenz
a multi focal visual outcome study using different near additions

Conditions: Cataract; Aphakia

Summary: a multi-centre non-randomized clinical investigation to assess multifocal visual outcomes using different near additions, for the treatment of aphakia after cataract removal.


Eligibility criteria:
inclusion criteria: * age-related cataract patients undergoing cataract surgery where the cataractous lens has been removed by phacoemulsification, with circular tear capsulotomy, leaving the posterior capsule intact * patients requiring primary iol implantation * patients with a potential corrected visual acuity of 20/40 or better on clinical assessment * patients with normal anterior segments - apart from cataracts * subjects with clear intraocular media other than cataract exclusion criteria: * pre-existing pathology or physiology, which may be aggravated by the implant, or may render the implant ineffective and that could potentially cause future acuity losses to a level of 0.5 or 20/40 or worse in either eye. this includes the following: * microphthalmia * corneal decompensation or endothelial insufficiency * pseudo exfoliation * high myopia * pars planitis * patient with greater than 1 dioptre of pre-operative corneal astigmatism * subjects who are expected to require retinal laser treatment * previous intraocular and/or corneal surgery * history of uveitis, glaucoma, proliferative diabetic retinopathy or iddm, pseudoexfoliation, macular degeneration that may affect potential best corrected visual acuity of 20/40 or better * operative complications of posterior capsular rupture, zonular dehiscence, incomplete continuous curvilinear capsulorhexis, severe iris /corneal trauma and inability to achieve secure placement in the designated location * subjects using a systemic medication that is known to cause ocular side effects * subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days * subjects who have only one eye with potentially good vision * patients who are not willing to cooperate in the 6-months follow-up period * children under the age of 18 years

Keywords: mflex multifocal 630f
dose finding study of recombinant human alpha-mannosidase for the treatment of patients with alpha-mannosidosis

Conditions: Alpha Mannosidosis

Summary: this is a single-center, open-label, multiple-dose study of the efficacy and long-term safety of lamazym for the treatment of patients with alpha-mannosidosis.


Eligibility criteria:
inclusion criteria: 1. the patient must have a confirmed diagnosis of alpha-mannosidosis as defined by alpha-mannosidase activity \< 10% of normal activity in blood leukocytes 2. the patient must have an age at the time of screening ≥ 5 year and ≤ 21 years 3. the patient must have physical ability to perform 6-minutes walk test (6mwt), 3 minute-stair climb test (3msct) and pulmonary lung function test (spirometry, body plethysmography). 4. the patient must have the ability to mentally cooperate in the cognitive and motor function tests 5. the patient must have the ability to hear and follow a request. hearing aids can be worn. 6. patient or patient's legally authorized guardian(s) must provide signed, informed consent prior to performing any study-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject) 7. the patient and his/her guardian(s) must have the ability to comply with the protocol exclusion criteria: 1. the patient cannot walk without support. 2. presence of known chromosomal abnormality and syndromes affecting psychomotor development, other than alpha-mannosidosis 3. history of bone marrow transplantation 4. presence of known clinically significant cardiovascular, hepatic, pulmonary or renal disease or other medical conditions that, in the opinion of the investigator, would preclude participation in the trial 5. presence of an echo with abnormalities within half a year that, in the opinion of the investigator, would preclude participation in the trial 6. any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the trial 7. pregnancy 8. psychosis within the last 3 months
scripps-emed covid-19 study: a prospective monitoring study for those individuals treated with paxlovid

Conditions: COVID-19

Summary: a prospective monitoring study for those individuals treated with paxlovid

the purpose of this study is to understand the epidemiology and pathophysiology of paxlovid rebound in patients with acute covid-19 infection who have been prescribed the paxlovid per standard of care. the study will be a collaborative effort between scripps and emed, digitally recruiting 800 participants who have tested positive for covid-19 and have agreed to be prescribed paxlovid on the emed platform. the vision of the study is to understand paxlovid rebound and ultimately inform management of acute covid-19 infection.

Eligibility criteria:
inclusion criteria: * age \> 18 * covid positive * qualified for paxlovid prescription (treatment decision already made prior to enrollment) exclusion criteria: * non-english speaking * resides outside of the united states

Keywords: paxlovid rebound covid-19
goreisan for heart failure (goreisan-hf) trial

Conditions: Heart Failure; Edema; Traditional Japanese Medicine; Kampo Medicine; Clinical Trial

Summary: the objective of the goreisan-hf trial is to assess the effect of the administration of goreisan (tj-17) plus standard therapy compared to standard therapy alone on the improvement rate of cardiac edema and clinical outcomes in worsening congestive heart failure with volume overload.

current guidelines recommend the use of loop diuretics as an indication for class i to improve hf symptoms regardless of left ventricular ejection fraction. loop diuretics, however, are known to activate the renin-angiotensin-aldosterone system and the sympathetic nervous system, which could accelerate hf progression. loop diuretics could also cause worsening renal function and electrolyte disturbance, and it is desirable to have an alternative drug to loop diuretics to effectively relieve congestive symptoms. goreisan (tj-17), a traditional japanese medicine composed of five herbal medicines, has long been used in japan to treat impairments of the regulation of body fluid homeostasis, including edema, and has been less likely to cause renal dysfunction and electrolyte abnormalities. we therefore planned a multicenter, randomized, interventional, parallel assignment, open-label treatment trial to evaluate the long-term effect of in-hospital initiation of goreisan, when added to standard therapy, in patients with worsening congestive heart failure and clear signs of volume overload.

Eligibility criteria:
inclusion criteria: * confirmed congestive heart failure (chf) by framingham criteria * chf patients with cardiac edema and signs due to cardiac edema (signs of fluid overload: lower limb edema, pulmonary effusion, or pulmonary congestion on chest x-ray) * elevated n-terminal pro brain-type natriuretic peptide (nt-probnp) ≥300 pg/ml or brain natriuretic peptide (bnp) ≥100 pg/ml at enrollment * patients ≥ 20 years of age, male or female * provision of signed informed consent before any assessment is performed exclusion criteria: * valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization * implantation of a cardiac resynchronization therapy (crt) within 12 weeks prior to enrollment or intent to implant a crt device * previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization * end-stage renal failure (estimated glomerular filtration rate \[egfr\] \<15 ml/min/1.73m2) at enrollment * patients who are expected to have a life expectancy of 6 months or less * acute coronary syndrome at screening * women of child-bearing potential or women who have a positive pregnancy test at enrolment or randomization * treatment with herbal medicine at enrollment * confirmed poor tolerability of goreisan (including cinnamon allergy) * considered not appropriate for the participation of the study

Keywords: heart failure edema traditional japanese medicine goreisan (tj-17) clinical trial
prognostic role of bowel ultrasound scan in children affected by acute severe colitis

Conditions: Acute Severe Colitis

Summary: asc is a life-threatening medical emergency. the lack of a timely intervention has shown to be associated with a mortality rate higher than 20% in adults, whereas a prompt targeted therapy has displayed a decrease of the aforementioned rate to 1%. therefore, the identification of predictors of poor outcome trough an objective tool may provide crucial help to individualize the timing of second line treatment initiation. at the state of the art, pucai represents the only validated tool to appraise the risk of first-line treatment failure and there is a lack of objective methods with a prognostic value in asc. bus has proven to be a reliable tool in assessing disease activity in children with uc and it has also shown statistically significant correlation with endoscopic features of disease activity. given the literature suggesting a role for bus in severe uc and the results from our retrospective study we aim to validate our findings trough a prospective assessment of the potential prognostic role of bus in asc.


Eligibility criteria:
inclusion criteria: * patients aged \< 18 years hospitalized for asc with diagnosis of uc established by the presence of accepted clinical, radiologic, endoscopic, and histologic criteria exclusion criteria: * patients with infectious colitis; * patients undergoing treatment with anti-tnf alpha agents; * patients already enrolled during the study period for a previous asc attack;